Catheter assembly

ABSTRACT

A catheter assembly including a catheter carried by a catheter adapter, a needle having a sharp distal tip and disposed in the catheter such that in a first needle position, the needle extending beyond the catheter, a septum actuator having openings, the septum actuator disposed in the catheter adapter and configured to pierce a septum, and a spring clip disposed in the septum actuator and engaging the openings of the septum actuator in the first needle position.

CROSS-REFERENCE

Related subject matter is disclosed in commonly assigned U.S. patentapplication Ser. No. 15/664,827, filed on Jul. 31, 2017, which isincorporated herein by reference in its entirety.

FIELD

Various exemplary embodiments of the invention relate to needleprotection and needle retraction in catheter assemblies.

BACKGROUND

Typical catheter assemblies incorporate one of two types of needleprotection mechanisms. An active system is a needle protection mechanismthat requires a separate user action to initiate needle protection, suchas depression of an activation button to activate automatic andinstantaneous needle retraction into a barrel assembly. This action cantake place after the needle is withdrawn from a skin of a patient andfrom the catheter. Alternately, depression of the activation button cantake place before the needle is withdrawn from the skin of the patientfor safety reasons, to reduce blood splatter and/or contamination. Onthe other hand, a passive system is a needle protection mechanism thatautomatically protects the needle when a user manually retracts theneedle from the catheter, typically using a spring clip and withoutrequiring a separate user action. In other words, the needle isimmediately protected when it is withdrawn from a skin of a patient andfrom the catheter.

Various disadvantages arise in each of the needle protection mechanisms.Specifically, in active systems, the user may neglect to depress theactivation button or fail to perform the secondary user action toprotect the needle. For example, when the activation button is notdepressed, the used needle tip that is covered in blood is undesirablyexposed from the body of a patient. In passive systems, the spring clipincludes undesirable sharp edges, blood is exposed on the needle and thespring clip, and the spring clip can be manually manipulated to exposethe distal tip of the needle after it is covered.

Additionally, blood control catheter assemblies have space requirementsthat invoke unique and creative design solutions to meet functionalrequirements within the restricted boundary.

SUMMARY OF THE INVENTION

It is an aspect of the present invention to provide a blood controlcatheter assembly where a spring clip is selectively engaged to a septumactuator during operation. Specifically, the spring clip includesflexible arms that are configured to enclose a distal end of the needleand simultaneously engage and disengage openings (flushing windows) inthe septum actuator. The flexible arms include a cutout portion thatallows the spring clip to engage and disengage with the openings of theseptum actuator with minimal interference and improved compactness tomeet size constraints. Alternately, the flexible arms can be narrowenough to allow the spring clip to engage and disengage with theopenings of the septum actuator in a similar manner as described above.The spring clip is advantageously not engaged and does not contact thecatheter adapter.

It is another aspect of the present invention to provide a blood controlcatheter assembly that incorporates both an active and passive system ina blood control catheter assembly. Such a catheter assembly remedies thedisadvantages above and improves needle protection and needleretraction. Specifically, the needle tip is enclosed by a spring clipand the needle is retracted into the barrel assembly. In this manner, ifthe user forgets to press the activation button, the distal tip isalready protected by the spring clip. When the activation button isdepressed, the needle and the spring clip retract into the barrelassembly, thereby protecting the user from all hazards. Alternately, theneedle and spring clip is retracted from the blood control catheterassembly manually by a user. Accordingly, the catheter assemblyadvantageously prevents needle re-exposure and reduces blood exposure.

The foregoing and/or other aspects of the present invention can beachieved by providing a catheter assembly including a catheter carriedby a catheter adapter, a needle having a sharp distal tip and disposedin the catheter such that in a first needle position, the needleextending beyond the catheter, a septum actuator having openings, theseptum actuator disposed in the catheter adapter and configured topierce a septum and a spring clip disposed in the septum actuator andengages the openings in the first needle position.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above aspects and features of the present invention will be moreapparent from the description for the exemplary embodiments of thepresent invention taken with reference to the accompanying drawings, inwhich:

FIG. 1 illustrates a side view of a first exemplary embodiment of acatheter assembly in a first needle position;

FIG. 2 illustrates a cross section view of the catheter assembly of FIG.1 moving toward a second needle position;

FIG. 3 illustrates a cross section view of a catheter adapter of FIG. 2;

FIG. 4 illustrates a partial cross section view of a barrel assembly ofFIG. 2;

FIG. 5 illustrates a partial cross section view of a needle hub in thebarrel assembly of FIG. 4;

FIG. 6 illustrates a side view of the catheter assembly of FIG. 1 in asecond needle position;

FIG. 7 illustrates a partial cross section view of the catheter assemblyof FIG. 1 moving toward a third needle position;

FIG. 8 illustrates a partial cross section view of the barrel assemblyof FIG. 1 in the third needle position;

FIG. 9 illustrates a partial cross section view of a spring clip in thebarrel assembly of FIG. 8;

FIG. 10 illustrates a partial cross section view of a second exemplaryembodiment of a catheter assembly moving toward a second needleposition;

FIG. 11 illustrates a partial cross section view of a catheter adapterof FIG. 10;

FIG. 12 illustrates a transparent perspective view of a spring clip anda clip housing of FIG. 11 moving toward a second needle position;

FIG. 13 illustrates a partial cross section view of a barrel assembly ofFIG. 10;

FIG. 14 illustrates a partial cross section view of a needle hub in thebarrel assembly of FIG. 13;

FIG. 15 illustrates a transparent perspective view of the spring clipand the clip housing of FIG. 10 in the second needle position;

FIG. 16 illustrates a top section view of the spring clip, clip housingand barrel assembly of FIG. 10 in the second needle position;

FIG. 17 illustrates a transparent cross section view of the spring clip,clip housing and the barrel assembly of FIG. 10 in the second needleposition;

FIG. 18 illustrates a transparent cross section view of the spring clip,clip housing and the barrel assembly of FIG. 10 in a third needleposition;

FIG. 19 illustrates a partial cross section view of the barrel assemblyof FIG. 10 in the third needle position;

FIG. 20 illustrates a cross section view of a third exemplary embodimentof a barrel assembly with a needle hub in a starting position;

FIG. 21 illustrates a cross section view of the barrel assembly of FIG.20 with the needle hub in an intermediate position;

FIG. 22 illustrates a cross section view of the barrel assembly of FIG.20 with the needle hub in an end position;

FIG. 23 illustrates a cross section view of a fifth exemplary embodimentof a blood control catheter assembly moving from a first needle positionto a second needle position;

FIG. 24 illustrates a cross section view of the blood control catheterassembly of FIG. 23 with a barrel assembly;

FIG. 25 illustrates a cross section view of the blood control catheterassembly of FIG. 23 in the second needle position;

FIG. 26 illustrates a cross section view of the blood control catheterassembly of FIG. 23 in a third needle position;

FIG. 27 illustrates a perspective view of a septum actuator of the bloodcontrol catheter assembly of FIG. 23;

FIG. 28 illustrates a perspective view of a spring clip commonly used ina blood control catheter assembly of the prior art;

FIG. 29 illustrates a top perspective view of a spring clip in the bloodcontrol catheter assembly of FIG. 23;

FIG. 30 illustrates a side perspective view of the spring clip in theblood control catheter assembly of FIG. 23;

FIG. 31 illustrates a perspective view of a septum in the blood controlcatheter assembly of FIG. 23; and

FIG. 32 illustrates a transparent perspective view of a spring clip andspring housing in a sixth exemplary embodiment of the blood controlcatheter assembly moving from a first needle position to a second needleposition.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIGS. 1-9 illustrate a first exemplary embodiment of a catheter assembly10. FIG. 1 illustrates the catheter assembly 10 in a first needleposition ready for operation. According to one embodiment, the catheterassembly 10 includes a hollow introducer needle 20 having a sharp distaltip 24 for insertion in a skin of a patient. The needle 20 is disposedin a flexible catheter 30. The catheter 30 is used for medicationdelivery during use of the catheter assembly 10. In the first needleposition, the sharp distal tip 24 of the needle 20 extends beyond thecatheter 30 for insertion.

According to one embodiment, the catheter 30 and the needle 20 arecarried or surrounded by a catheter adapter 32. FIG. 2 illustrates theneedle 20 moving from the first needle position toward a second needleposition after the user has placed the catheter 30 in the body of thepatient and removed the needle 20 from the patient.

FIG. 3 illustrates, according to one embodiment, the catheter adapter 32when the needle 20 is pulled back and approaching the second needleposition. The catheter adapter 32 includes a retention feature 34comprising a protrusion. The retention feature 34 retains a metal springclip 40 when the spring clip 40 is in an open position as illustrated.Operation of the spring clip 40 is further described below.

The spring clip 40 is disposed in the catheter adapter 32 and cooperateswith the needle 20 by selectively enclosing and locking the sharp distaltip 24 of the needle 20. Components and operation of the spring clip 40are generally disclosed in U.S. Pat. No. 6,616,630, which is herebyincorporated by reference in its entirety.

Specifically, according to one embodiment, the spring clip 40 includesan opening 42 where the needle 20 passes through. One or more flexiblearms 44 of the spring clip 40, preferably two flexible arms 44, engageand bias the needle 20 in the open position prior to the needle enteringthe second needle position. The flexible arms 44 apply a spring force totwo sides of the needle 20. In the first needle position and prior tothe second needle position, the spring clip 40 is open to allow theneedle 20 to pass through.

At the distal end of the flexible arms 44 include distal walls 50. Thedistal walls 50 are angled walls have lips 52 at one end which contactthe needle 20. The lips 52 are folded inward portions of distal walls 50of the spring clip 40.

The spring clip 40 further includes a rear wall 46. The rear wall 46 issubstantially perpendicular to a longitudinal axis of the needle 20 andconnects the two flexible arms 44 to each other. The rear wall 46 alsoincludes the opening 42 as described above. The rear wall 46 preferablyincludes a tapered outer surface 48. In another embodiment, the taperedouter surface 48 comprises a radius or a chamfer. As further describedbelow, the tapered outer surface 48 advantageously provides guidedmovement of the spring clip 40 into a handle 71 and a barrel 72.

FIGS. 4 and 5 illustrate the barrel assembly 70. According to oneembodiment, the barrel assembly 70 includes the handle 71 (also referredto as a grip) and the barrel 72 (also referred to as barrel housing).The handle 71 includes an inner diameter 74 and a tapered inner surface76 at a distal end of the handle 71. In another embodiment, the taperedinner surface 76 comprises a radius or a chamfer. In another embodiment,the tapered inner surface 76 connects and provides a transition betweenan outer surface of the handle 71 and an inner surface of the handle 71.A distal end of the barrel 72 is connected to a proximal end of thehandle 71 during operation.

In this embodiment, the catheter assembly 10 includes both the taperedinner surface 76 at the distal end of the handle 71 and the taperedouter surface 48 of the spring clip 40. In an alternate embodiment, thecatheter assembly 10 includes only the tapered inner surface 76 at thedistal end of the handle 71. Likewise, in an alternate embodiment, thecatheter assembly 10 includes only the tapered outer surface 48 of thespring clip 40. In another embodiment, the catheter assembly 10 does notinclude either of the tapered inner surface 76 at the distal end of thehandle 71 or the tapered outer surface 48 of the spring clip 40.

The tapered inner surface 76 is configured to cooperate with the taperedouter surface 48 of the spring clip 40 to advantageously engage andguide the spring clip 40 into the handle 71 and the barrel 72. Also, thetapered outer surface 48 advantageously engages the tapered innersurface 76 to center the spring clip 40 with respect to the handle 71and the barrel 72. The handle 71 and the barrel 72 houses the componentsof the barrel assembly 70 as further described below.

The barrel assembly 70 further includes a needle hub 80. The needle hub80 is fixed to the needle 20 and moves within the handle 71 and thebarrel 72. Specifically, the needle hub 80 is fixed adjacent to aproximal end of the needle 20. As illustrated in FIG. 1, the needle hub80 is connected to the catheter adapter 32 when the needle 20 is in thefirst needle position. Movement of the needle hub 80 causes the needleto retract from the second needle position to a third needle position asdescribed below.

The handle 71 and the barrel 72 also interacts with an activation button78 to engage and release the needle hub 80 and a spring 82.Specifically, the spring 82 is disposed about the needle 20 andextending between the needle hub 80 and the proximal end of the barrel72. The activation button 78 contacts the needle hub 80 while the spring82 is compressed. When the activation button 78 is depressed, the needlehub 80 no longer contacts the activation button 78 and the spring 82 issubsequently released to move the needle hub 80 through the handle 71and toward a proximal end of the barrel 72. That is, the activationbutton 78 is movably mounted adjacent to the distal end of the barrel 72and adapted for selective engagement with the needle hub 80 to hold theneedle hub 80 adjacent to the distal end of the barrel 72 against thebias of the spring 82. In the first needle position, the needle 20extends beyond the distal end of the handle 71 and the barrel 72 andthrough the catheter 30 with the catheter hub 32 adjacent to the distalend of the barrel 72. Operation of the activation button 78 is describedin U.S. Pat. Nos. 5,501,675 and 5,797,880, which are hereby incorporatedby reference in their entirety. Further description of the operation isprovided below.

According to one embodiment, FIG. 6 illustrates the catheter assembly 10in the second needle position. In this position, the sharp distal tip 24of the needle 20 is disposed in the spring clip 40 and shielded from anexternal environment. The user moving the needle 20 from the firstneedle position to the second needle position corresponds to a passivesystem. This is because the needle 20 is removed from the skin of thepatient and the spring clip 40 protects the needle 20 in the same manualoperation.

As illustrated in FIG. 7, the spring clip 40 is in a closed positionwhere the two flexible arms 44 bias against each other to enclose thesharp distal tip 24 of the needle 20. In another words, the distal walls50 and the lips 52 overlap each other to close the spring clip 40 in aclosed position. Specifically, the lip 52 of one flexible arm 44contacts the distal wall 50 of the other flexible arm 44. The twoflexible arms 44 of the spring clip 40 no longer bias the needle 20.Accordingly, the flexible arms 44 close the distal end of the springclip 40 to prevent the needle 20 from exiting.

The needle 20 also includes a needle deformation 22 that provides theneedle 20 with a local diameter that is larger than the diameter of theopening 42 in the spring clip 40. The needle deformation 22 prevents theneedle 20 from exiting the spring clip 40 at its proximal end. Othermeans of retaining the sharp distal tip 24 inside the spring clip 40includes the spring clip engaging a plate or a notch in the needle asdescribed in U.S. Pat. No. 4,952,207, which is hereby incorporated byreference in its entirety.

When the spring clip 40 is disposed in the closed position, the springclip 40 no longer engages the retention feature 34 of the catheteradapter 32. Thus, as illustrated in FIG. 6, the spring clip 40 is nolonger retained in the catheter adapter 32 and is now able to be removedfrom the catheter adapter 32.

FIG. 8 illustrates, according to one embodiment, the barrel assembly 70when the catheter assembly 10 is in the third needle position. Asdescribed above, when the activation button 78 is depressed, the spring82 and the needle hub 80 are released and retracted to the proximal endof the barrel 72. That is, the activation button 78 triggers operationalmovement of the needle 20, the spring clip 40 and the needle hub 80 tobe enclosed in the barrel 72. During this movement, the tapered innersurface 76 of the inner diameter 74 of the handle 71 cooperates with thetapered outer surface 48 of the spring clip 40 to advantageously engageand guide the spring clip 40 into the handle 71 and the barrel 72. Also,the tapered outer surface 48 engages the tapered inner surface 76 toadvantageously center the spring clip 40 with respect to the handle 71and the barrel 72.

Movement from the second needle position to the third needle positioncorresponds to an active system. This is because a secondary stepsubsequent to the initial withdrawal of the needle 20 from the skin ofthe patient takes place. Specifically, in this secondary step, the userdepresses the activation button 78 causing the needle 20 toautomatically retract via a spring force from the spring 82. Thus, inthis third needle position, the sharp distal tip 24 and the spring clip40 are safely enclosed in the barrel 72.

According to one embodiment, if the catheter 30 is inserted into theskin of a patient and the activation button 78 is depressed, the needle20 and the needle hub 80 are immediately withdrawn into the barrelassembly 70. Under this scenario, the tip shielding of the second needleposition automatically takes place. This movement corresponds to thepassive system.

Typically, in the prior art, spring clips are not retracted into abarrel. Either spring clips are used to cover a sharp distal tip of aneedle or a needle without a spring clip is retracted into the barrel.The catheter assembly 10 disclosed herein advantageously combines anactive and a passive system to ensure increased safety to the user andreduces blood exposure and splatter. The catheter assembly 10 improvesoperation by providing the tapered inner surface 76 of the innerdiameter 74 of the handle 71 to cooperate with the tapered outer surface48 of the spring clip 40.

FIGS. 10-19 illustrate a second exemplary embodiment of a catheterassembly 110. The catheter assembly 110 is a modified version of thecatheter assembly 10 described above with the following differences.FIG. 10 illustrates the catheter assembly 110 when the user removes aneedle 120 from a distal end of a catheter 130 and positions a sharpdistal tip 124 of the needle 120 into a catheter adapter 132.

FIG. 11 illustrates, according to one embodiment, the needle 120 insidethe catheter adapter 132. As similarly described in the previousembodiment, a spring clip 140 selectively opens and closes to expose andenclose the sharp distal tip 124 of the needle 120. The spring clip 140includes an opening 142 for the needle 120 to travel through. The springclip 140 also includes a curved portion 154, distal walls 150 and lips152 to enclose the sharp distal tip 124. The curved portion 154 isconfigured so that flexible arms 144 appropriately flex between open andclosed positions of the spring clip 140. Additionally, the spring clip140 includes a rear wall 146 and a tapered outer surface 148 at aproximal end of the spring clip 140. The catheter adapter 132 furtherincludes a retention feature 134 that retains the spring clip 140 viathe flexible arms 144 until the spring clip 140 is closed.

According to one embodiment, FIGS. 11 and 12 also illustrate a cliphousing 156 that partially surrounds the spring clip 140. Features andoperation of the clip housing 156 are similarly disclosed in U.S. patentapplication Ser. No. 15/481,166 filed on Apr. 6, 2017, which is herebyincorporated by reference in its entirety. Specifically, the cliphousing 156 advantageously covers any sharp edges in the spring clip 140to protect the user from inadvertent contact. The clip housing 156 alsoincludes locking and/or engagement features to prevent inadvertentseparation from the spring clip 140.

The flexible arms 144 of the spring clip 140 extend outside of the cliphousing 156 in the open position of the spring clip 140. The cliphousing 156 of this embodiment also advantageously includes a taperedouter surface 158 at a distal end of the clip housing 156. In anotherembodiment, the tapered outer surface 158 comprises a radius or achamfer. The tapered outer surface 158 is configured to advantageouslyprovide guided movement of the clip housing 156 into a handle 171 and abarrel 172 as further described below and as similarly described in theprevious embodiment. Also, the tapered outer surface 158 advantageouslycenters the spring clip 140 with respect to the handle 171 and thebarrel 172. Accordingly, the tapered outer surface 158 of the cliphousing 156 cooperates with the tapered outer surface 148 at the rearwall 146 of the spring clip 140 to advantageously provide smooth travelinto the handle 171 and the barrel 172.

According to one embodiment, FIGS. 13 and 14 illustrate a barrelassembly 170. As similarly described in the previous embodiment, thebarrel assembly 170 includes the handle 171 having an inner diameter174. The inner diameter 174 includes a tapered inner surface 176disposed at a distal end of the handle 171. The tapered inner surface176 of the inner diameter 174 of the handle 171 cooperates with thetapered outer surface 148 of the spring clip 140 and the tapered outersurface 158 of the clip housing 156 to advantageously engage and guidethe spring clip 140 and the clip housing 156 into the handle 171 and thebarrel 172. Also, the tapered outer surface 148 of the spring clip 140and the tapered outer surface 158 of the clip housing 156 engage thetapered inner surface 176 to advantageously center the spring clip 140and the clip housing 156 with respect to the handle 171 and the barrel172.

As similarly described in the previous embodiment, the barrel assembly170 further includes an activation button 178 and a spring 182 thatcooperates with a needle hub 180 for retraction. The needle 120 is fixedto the needle hub 180 so that the needle 120 is retracted into thebarrel 172 when the activation button 178 is depressed.

FIG. 15 illustrates, according to one embodiment, the spring clip 140being substantially disposed in the clip housing 156 and in a closedposition where the needle is in a second needle position. Specifically,the distal walls 150 are offset and the lip 152 of one of the distalwalls 150 contacts the other distal wall 150 to block the distal tip 124of the needle 120 from exiting the clip housing 156. Also, after thespring clip 140 is in the closed position, a distal portion of thespring clip 140 may extend beyond the clip housing 156.

According to one embodiment, FIG. 16 illustrates a top section view andFIG. 17 illustrates a cross section view of the spring clip 140 and theclip housing 156. Both of these figures illustrate the spring clip 140and the clip housing 156 being retracted into the barrel 172 from thesecond needle position to a third needle position.

As similarly described in the previous embodiment, FIGS. 18 and 19illustrate the spring clip 140 and the clip housing 156 in the barrel172. This is the third needle position of the needle 120 of the catheterassembly 110.

FIGS. 20-22 illustrate a third exemplary embodiment of a barrel assembly270. The barrel assembly 270 is a modified version of the barrelassembly 70, 170 described above with the following improvements tocontrol a retraction speed of a needle 220 in a handle 271 and a barrel272.

In the previous embodiments described above, when the activation button78, 178 is depressed, the needle hub 80, 180 is retracted into thehandle 71, 171 and the barrel 72, 172 via force from the spring 82, 182.However, the retraction speed of the needle hub 80, 180 may be high,which can cause blood to splatter during retraction. Various dampingmechanisms have been used in the prior art including a silicone gel,bladder air vents, O-rings, a crushable filter and spring compressionnodes as described in U.S. Pat. Nos. 5,575,777, 5,702,367 and 6,090,078,which are hereby incorporated by reference in their entirety.

According to one embodiment, the barrel assembly 270 provides acontrolled variable retraction speed of the needle 220 into the handle271 and the barrel 272 of the catheter assembly. Specifically, thehandle 271 includes a first inner diameter 274 a, a second innerdiameter 274 b and a third inner diameter 274 c. The first innerdiameter 274 a and the third inner diameter 274 c are substantiallysimilar. Also, the second inner diameter 274 b is greater than each ofthe first inner diameter 274 a and the third inner diameter 274 c,respectively. The three inner diameters 274 a, 274 b, 274 c areconnected via inner diameter tapers to provide a continuous changinginner diameter.

The barrel assembly 270 further includes a needle hub 280 that securesthe needle 220. A first damping mechanism 290 is advantageously fixed toa proximal end of the needle hub 280. In one embodiment, the firstdamping mechanism 290 is a silicone washer or a silicone disc.

In operation of the catheter assembly, when the activation button 78,178 is depressed, an outer diameter of the first damping mechanism 290is in frictional contact with the first inner diameter 274 a. This isbecause the first inner diameter 274 a is smaller than the outerdiameter of the first damping mechanism 290. As a result, the needle hub280 and needle 220 advantageously begin to move slowly into the handle271 and the barrel 272.

As the needle hub 280 continues to move in the handle 271 and the barrel272, the inner diameter increases in size to the second inner diameter274 b. The second inner diameter 274 b is larger than the outer diameterof the first damping mechanism 290. Accordingly, there is clearance(significantly reduced frictional contact) between the second innerdiameter 274 b and the first damping mechanism 290. As a result, theneedle hub 280 advantageously picks up speed and moves faster throughthe handle 271 and the barrel 272.

As the needle hub 280 approaches the end of its travel in the barrel272, the inner diameter of the barrel 272 decreases in size to the thirdinner diameter 274 c. The outer diameter of the first damping mechanism290 is in frictional contact with the third inner diameter 274 c. Thisis because the third inner diameter 274 c is smaller than the outerdiameter of the first damping mechanism 290. As a result, the needle hub280 advantageously slows down in speed as it approaches the end oftravel in the barrel 272.

The catheter assembly incorporating the barrel assembly 270 of thisembodiment advantageously provides slow needle retraction at thebeginning and at the end of the needle travel to reduce blood splatterand provide smooth movement of the needle 220 and needle hub 280 duringretraction. The changing diameters in the handle 271 and the barrel 272advantageously provide a speed damping profile to control the speed ofthe needle retraction at various positions.

The speed damping profile can be adjusted based on the desiredretraction speed of the needle 220 and the needle hub 280. According toone embodiment, the third inner diameter 274 c is smaller than the firstinner diameter 274 a to advantageously provide a slower retraction speedat the end of travel compared to at the beginning of travel. Accordingto another embodiment, the first inner diameter 274 a is smaller thanthe third inner diameter 274 c to advantageously provide a slowerretraction speed at the beginning of travel compared to at the end oftravel. According to one embodiment, the second inner diameter 274 b issubstantially similar to the first and third inner diameters 274 a, 274c to advantageously provide a slow retraction speed of the needle 220and needle hub 280 throughout travel in the handle 271 and the barrel272.

According to one embodiment, the width of each of the inner diameters274 a, 274 b, 274 c are varied to adjust the speed damping profile.Specifically, the width of the inner diameters 274 a, 274 b, 274 cadvantageously control an amount of time for retraction at each portionof the handle 271 and the barrel 272 as the needle 220 and the needlehub 280 travel through the handle 271 and the barrel 272. The amount offriction between the inner diameters 274 a, 274 b, 274 c and the firstdamping mechanism 290 (how much interference is present), as well as thestrength of the spring 82, 182 also advantageously controls the amountof time for retraction at each portion of the handle 271 and the barrel272.

A fourth exemplary embodiment of a catheter assembly is a modifiedversion of the barrel assembly 270 described above with the followingdifferences. Specifically, the handle 271 and the barrel 272 include afirst and second inner diameter 274 a, 274 b as similarly describedabove. The barrel assembly 270 also includes a first damping mechanism290 being fixed at a proximal end of a needle hub 280. The barrelassembly 270 further includes a second damping mechanism 291. The firstdamping mechanism 290 is a silicone washer as similarly described aboveand the second damping mechanism 291 is a silicone gel. The silicone gel291 is applied at a proximal end of the spring 82, 182 prior toretraction. FIGS. 4, 5, 13, 14, 17-19 illustrate an exemplary accesshole 292 that is provided in the handle 71, 171 for the user to supplythe silicone gel 291.

In operation of the catheter assembly with the barrel assembly 270 ofthis embodiment, when the activation button 78, 178 is depressed, anouter diameter of the first damping mechanism 290 is in frictionalcontact with the first inner diameter 274 a. This is because the firstinner diameter 274 a is smaller than the outer diameter of the firstdamping mechanism 290. As a result, the needle hub 280 and needle 220advantageously begin to move slowly into the handle 271 and the barrel272 during retraction.

As the needle hub 280 continues to move in the handle 271 and the barrel272, the inner diameter of the handle 271 and the barrel 272 increasesto the second inner diameter 274 b. The second inner diameter 274 b islarger than the outer diameter of the first damping mechanism 290.Accordingly, there is significantly less frictional contact between thesecond inner diameter 274 b and the first damping mechanism 290. As aresult, the needle hub 280 advantageously picks up speed and movesfaster through the handle 271 and the barrel 272 during retraction.

As the needle hub 280 approaches the end of its travel in the barrel272, the spring 82, 182 advantageously begins to move through theapplied silicone gel of the second damping mechanism 291. The siliconegel of the second damping mechanism 291 resists the extension of thespring 82, 182 to advantageously slow the retraction of the needle 220and the needle hub 280. Accordingly, the combination of the first andsecond damping mechanisms 290, 291 advantageously provides a similarspeed damping profile during needle retraction as the third embodimentdescribed above.

This configuration advantageously reduces the manufacturing complexitiesof more than two controlled inner diameters in the handle 271 and thebarrel 272. Also, the combination of the silicone washer 290 and thesilicone gel 291 advantageously provide similar damping characteristicswhile reducing blood splatter and provides smooth movement of the needle220 and the needle hub 280 during retraction.

According to one embodiment, the silicone gel of the second dampingmechanism 291 is applied to the distal end of the spring 82, 182, aswell as the proximal end of the inner diameter of the handle 271. Inthis manner, the silicone gel 291 is in contact with the spring 82, 182in the compressed state, as well as when the spring 82, 182 moves to itsextended state. Accordingly, the silicone gel 291 resists the extensionof springs 82, 182 while contacting the needle hub 280 to slow itsmovement throughout travel. Applying silicone gel 291 in this manneradvantageously allows coils of the springs 82, 182 to expand one at atime, instead of all at once.

Such a configuration advantageously improves the accuracy of the speeddamping profile during needle retraction, particularly at the beginningof travel by slowly permitting the initial movement of the needle hub280 after initial activation. This configuration also advantageouslyavoids the use of a silicone washer 290, which is susceptible toproviding excessive friction upon activation. Under this scenario, thefrictional force is greater than the spring force and thus, the needle220 does not retract and remains in an unsafe condition. Accordingly,the silicone gel 291 advantageously provides a strong solution for theinitial, activation phase.

According to one embodiment, the silicone gel 291 is provided to thedistal end of the spring 82, 182 in the compressed state and thesilicone washer 290 is fixed to the proximal end of the needle hub 280.The silicone washer 290 only significantly contacts the inner diameterof the barrel 272 near the end of travel to provide a significantfrictional force. In this manner, the silicone gel 291 advantageouslyprovides a strong solution for the initial, activation phase, assimilarly described above, while the silicone washer 290 provides abetter slow/speed reduction solution at the end of travel. Using thesilicone washer 290 at the end of travel instead of silicone gel 291advantageously avoids the needle hub 280 from simply “crashing” into apile of silicone gel 291 at the end and provides better speed reduction.

In another embodiment, the silicone washer as the first dampingmechanism 290 is disposed at the proximal end of the needle hub 280 andthe silicone gel as the second damping mechanism 291 is disposed at theproximal end of the inner diameter of the barrel 272. The siliconewasher interacts with the inner diameter of the handle 271 and thebarrel 272 to control initial retraction of the needle hub 280 assimilarly described above. The silicone gel at the proximal end of theinner diameter of the barrel 272 contacts the needle hub 280 to slow theend of travel in the barrel 272. Such a configuration advantageouslyprovides another way to control the speed damping profile during needleretraction.

In another embodiment, the silicone gel as the second damping mechanism291 is disposed at the proximal end of the needle hub 280, applied tothe spring 82, 182 and disposed at the proximal end of the innerdiameter of the barrel 272. The silicone gel at the proximal end of theneedle hub 280 contacts the inner diameter of the handle 271 to slow theretraction speed. A similar effect happens with the silicone gel 291 atthe proximal end of the inner diameter of the barrel 272 as the needlehub 280 approaches the end of travel in the barrel 272. However, at theproximal end of the inner diameter of the barrel 272, the spring alsomixes with the residual silicone gel from the proximal end of the needlehub 280 to provide further damping of the retraction speed.

In this manner, the silicone gel 291 advantageously slows retraction ofthe needle hub 280 at the end to obtain a smoother deceleration andstoppage of the needle hub 280 in the retracted position. Such aconfiguration advantageously provides another way to control the speeddamping profile during needle retraction while only using silicone gel.In another embodiment, access holes 292 are advantageously provided nearany one of the proximal end of the spring 82, 182, the proximal end ofthe needle hub 280 in the first needle position and the proximal end ofthe inner diameter of the handle 271 and the barrel 272. In this manner,silicone gel 291 can be easily and accurately applied by the user at thedesired locations described in the embodiments above.

FIGS. 23-26 illustrate a fifth exemplary embodiment of a catheterassembly 310. The catheter assembly 310 of this embodiment is a bloodcontrol catheter assembly that uses many of the features described inthe embodiments above. Specifically, the catheter assembly 310 includesa catheter 330, a catheter adapter 332 and a retention feature 334, aswell as a needle 320, a needle deformation 322 and a sharp distal tip324 in a similar manner as described above.

A mating portion 364 is disposed at a proximal end of the catheteradapter 332. The mating portion 364 permits fluid flow and receives orengages or abuts an end of a Luer connector or device (not shown). Themating portion 364 preferably allows fluid to be exchanged between theLuer connector and the catheter 330 during engagement.

The mating portion 364 advantageously includes a Luer engagement surfaceof at least 7.5 mm in length. Such a configuration satisfies recentlyupdated ISO 594 standard, which is now ISO 80369-7, entitled Small-BoreConnector Standard. This new ISO standard controls size and variation ofall small-bore connectors to reduce misconnection between the variousstandard sub-types, thus avoiding inaccurate Luer connections in thedesign of the catheter adapter 332. Accordingly, satisfying the newrequirements of ISO 80369-7 invokes a greater need to optimize space andto develop a compact design of the catheter assembly 310.

The catheter assembly 310 includes a septum 314 that regulates the flowof fluid. As best illustrated in FIG. 31, the septum 314 has one or morepre-formed openings or slits designed to selectively prevent unwantedfluid flow through the septum 314. Three intersecting slits formingthree flaps open when engaged by a septum actuator 360, as described indetail below.

The septum 314 shown in FIG. 31 may be used in any of the embodimentsdiscussed herein. Other septum configurations may be used as would beunderstood by one of ordinary skill in the art. The septum 314 is madeof an elastic material to form the valve, for example silicone rubber.Other elastic materials may be used and non-elastic materials may beincorporated in the septum 314 as needed.

The catheter assembly 310 further includes the septum actuator 360 asbest illustrated in FIG. 27. Septum actuators 360 similar to that ofFIG. 27 may be used in any of the embodiments described herein. Theseptum actuator 360 is positioned in the catheter adapter 332 and isaxially moveable in the catheter adapter 332 to engage (open the slitsof) and disengage (close the slits of) the septum 314. The septumactuator 360 is preferably made in one piece from a rigid or semi-rigidmaterial, for example a rigid polymer material or a metal.

The septum actuator 360 includes an internal passage 362 a that spans afull length of the septum actuator 360. The septum actuator 360 is asubstantially tubular member and the internal passage 362 a issubstantially cylindrical to provide a hollow passage in the septumactuator 360 so that fluid can be exchanged through the septum 314 whenthe septum 314 is opened and/or penetrated by the septum actuator 360.The internal passage 362 a is in fluid communication with the distalopening 362 b disposed at the distal end of the septum actuator 360.

One or more openings 362 c are disposed at various positions between theproximal and distal ends of the septum actuator 360. The openings 362 cof the septum actuator 360 are similarly described in U.S. Pat. No.9,101,746, which is hereby incorporated by reference in its entirety.These openings 362 c act as flushing windows to provide fluid exchangeand flushing in and through the septum actuator 360. Each of theopenings 362 c has a width larger than a width of the flexible arms 344as further described below. The openings 362 c extend through the septumactuator 360 in a direction substantially perpendicular to a centerlineof the internal passage 362 a. The openings 362 c are in fluidcommunication with the internal passage 362 a to permit fluid flowthrough and around the septum actuator 360.

The openings 362 c advantageously provide increased area for the fluidto move inside the catheter adapter 332 of the catheter assembly 310.The increased area advantageously allows for fluid flushing and toprevent coagulation of fluid in the proximal and distal ends of theseptum 314, as well as in the proximal and distal ends of the catheteradapter 332. As a result, the openings 362 c advantageously minimize thestagnation of fluid and allow for greater mixing.

Finally, the openings 362 c also advantageously and simultaneously allowengagement by a spring clip 340 as described below. Such an engagementbetween the spring clip 340 and the septum actuator 360 advantageouslyoptimizes space and provides a compact design of the catheter assembly310. A shorter length of the catheter assembly 310 normally createsreduced flushing performance. However, the embodiments of the catheterassembly 310 advantageously use the openings 362 c of the septumactuator 360 in a dual manner of fluid flushing and interlocking withthe spring clip 340 to achieve size benefits while maintaining optimalperformance.

The septum actuator 360 also includes a flange 366 that engages theretention feature 334 in the catheter adapter 332. Specifically, anouter diameter of the flange 366 is larger than an inner diameter of theretention feature 334. Accordingly, the retention feature 334 restrainsthe septum actuator 360 in the catheter adapter 332 so that the septumactuator 360 and the spring clip 340 are not inadvertently displaced orremoved.

After the catheter 330 is placed into the skin of the patient, thecatheter assembly 310 can be accessed and/or used either once ormultiple times by a practitioner. In the former case, the septumactuator 360 remains engaged with the septum 314 after the Luerconnector is removed. In the latter case, the septum actuator 360 isconfigured to move between a first actuator position and a secondactuator position. In the first actuator position, the septum actuator360 pierces the septum 314 and establishes fluid communication with thecatheter 330 and the proximal end of the catheter adapter 332. In thesecond actuator position, the septum actuator 360 no longer pierces theseptum 314 prohibiting fluid communication between the catheter 330 andthe proximal end of the catheter adapter 332.

The septum actuator 360 can move from the first actuator position to thesecond actuator position in a variety of ways. In one embodiment, areturn member such as a spring (not shown) engages an inner diameter ofthe catheter adapter 332 and an outer diameter of the septum actuator360. The spring is compressed when the septum actuator 360 moves intothe first actuator position. After use, as further described below,spring force from the spring causes the septum actuator 360 to move fromthe first actuator position to the second actuator position.

In another embodiment, the elasticity of the septum 314 does not allowthe septum actuator 360 to fully pierce the septum 314 in the firstactuator position. Rather, the septum 314 is partially pierced by theseptum actuator 360. Accordingly, after use, as further described below,the elasticity of the septum 314 provides a force that moves the septumactuator 360 to the second actuator position.

The catheter assembly 310 further includes the spring clip 340 disposedin the septum actuator 360. The spring clip 340 includes many of thefeatures described above such as an opening 342, flexible arms 344, arear wall 346, a tapered outer surface 348, distal walls 350 and a lip352. FIG. 28 illustrates a spring clip 440 known in the prior art, whileFIGS. 29 and 30 illustrate the exemplary spring clip 340 in thisembodiment of the catheter assembly 310. Further information about thespring clip 440 of the prior art as illustrated in FIG. 28 is disclosedin U.S. Pat. No. 8,337,463, which is hereby incorporated by reference inits entirety.

The flexible arms 344 in the spring clip 340 illustrated in FIGS. 29 and30 include a proximal arm portion 345 a and a distal arm portion 345 b.The proximal arm portion 345 a is wider than the distal arm portion 345b to advantageously provide the necessary flexibility and spring forceduring operation. The distal arm portion 345 b includes a cutout havinga curvature or section that is narrower than a remaining section of thedistal arm portion 345 b. This cutout in the distal arm portion 345 b isnot present in the spring clip 440 of the prior art as illustrated inFIG. 28.

FIGS. 29 and 30 also illustrate the distal walls 350 of the flexiblearms 344 of the spring clip 340 to each include a top wall portion 351 aand a bottom wall portion 351 b. The top wall portion 351 a is narrowerthan the bottom wall portion 351 b. Specifically, the top wall portion351 a includes a cutout having a curvature or section, similarly to thedistal arm portion 345 b. Again, similar to the distal arm portion 345b, the cutout in the top wall portion 351 a is not present in the springclip 440 of the prior art as illustrated in FIG. 28.

The cutouts in the distal arm portion 345 b and the top wall portion 351a meet at the highest section of the spring clip 340. The highestsection of the spring clip 340 extends into and out of the openings 362c of the septum actuator 360 during operation. These cutouts areadvantageously provided so that the flexible arms 344 can engage anddisengage the openings 362 c of the septum actuator 360 during operationwhile minimizing or eliminating contact with the openings 362 c.Specifically, a width of the cutouts is advantageously smaller than awidth of the openings 362 c of the septum actuator 360 to allow properoperation.

Accordingly, no unnecessary friction is produced, the life of the springclip 340 is optimized, and the spring clip 340 can operate withoutinterference. Also, the spring clip 340 does directly contact or engagethe catheter adapter 332 to advantageously optimize space and provide acompact design of the catheter assembly 310. Finally, the openings 362 cof the septum actuator 360 are advantageously used in a dual manner offluid flushing and interlocking with the spring clip 340 to achieve acompact design while maintaining optimal performance.

In another embodiment (not illustrated), the flexible arms of the springclip are narrower than the flexible arms 344 of the spring clip 340described above. The spring clip is narrow enough to engage anddisengage the openings 362 c of the septum actuator 360 in a similarmanner as described above. Specifically, the narrower flexible armsreplace the cutouts in the distal arm portion 345 b and the top wallportion 351 a of the spring clip 340 to achieve the same benefits andadvantages as described above.

In a first needle position as similarly described in previousembodiments, the flexible arms 344 of the spring clip 340 are biased onthe needle 320. In this embodiment, the flexible arms 344 protrude intoor engage the openings 362 c of the septum actuator 360. This engagementprevents removal of the spring clip 340 from the septum actuator 360.

In a second needle position as similarly described in previousembodiments, the flexible arms 344 of the spring clip 340 enclose thedistal tip 324 of the needle 320. The spring clip 340 protects thedistal tip 324 from further use or inadvertent contact. In thisembodiment, the flexible arms 344 retract from and disengage theopenings 362 c of the septum actuator 360. This disengagement allows forthe removal of the spring clip 340 from the septum actuator 360.

Accordingly, due to the disengagement described above, the spring clip340 and the needle 320 can move from the second needle position to athird needle position. The third needle position separate and removesthe spring clip 340 and the needle 320 from the catheter adapter 332 ofthe catheter assembly 310. Moving between the first, second and thirdneedle positions can occur either manually or automatically as furtherdescribed below.

Various alternative designs of the spring clip 340 are contemplated inthis application, although not illustrated. For example, the spring clip340 can be made of plastic, metal or a combination of both. A resilientband can be disposed around the spring clip 340 to assist in closing thespring clip 340 and enclosing the distal end of the needle 320. Examplesof alternative spring clips are those described in U.S. PatentApplication Publication Nos. 2012/0136311, 2013/0030391, 2013/0184645,2013/0178800, 2014/0121604 and 2017/0043135, which are herebyincorporated by reference in their entirety. Any of these alternativespring clips can be modified to operate similarly to the spring clip 340in the catheter assembly 310 disclosed herein.

FIG. 24 also illustrates a barrel assembly 370 optionally connected tothe catheter assembly 310. The barrel assembly 370 includes a grip 371,an activation button 378 and a spring 382, as well as other featuresdescribed above. The barrel assembly 370 provides automatic withdrawalof the needle 320 when moving from the first needle position to thesecond needle position and finally to the third needle position. Inanother embodiment of the catheter assembly 310, a barrel assembly isnot present. Rather, the needle 320 is manually moved from the firstneedle position to the second needle position and ultimately to thethird needle position by a user.

FIG. 32 illustrates a sixth exemplary embodiment of the catheterassembly 310 where the spring clip 340 is enclosed by a spring housing356 in a similar manner as described above. The spring clip 340 and thespring housing 356 are disposed in the septum actuator 360 in the firstand second needle positions of the catheter assembly 310. Subsequently,the spring clip 340, the spring housing 356 and the needle 320 areremoved from the septum actuator 360 of the catheter assembly 310 in thethird needle position.

The operation of the catheter assembly 310 is described below. Thecatheter 330 and the needle 320 are inserted into a vein of a patient inthe first catheter assembly position. When the needle 320 and catheter330 are securely disposed, the activation button 378 is depressed. Upondepression of the activation button 378, an inner needle hub and thespring 382 are disengaged from a wall (not illustrated in FIG. 24 butillustrated in previous embodiments) of the activation button 378. Theneedle 320 then retracts into the catheter adapter 332 via spring forcefrom the spring 382. In another embodiment, when the needle 320 andcatheter 330 are securely disposed, the needle 320 is withdrawn by auser manually and without the use of the barrel assembly 370.

As the needle 320 retracts into the catheter adapter 332, eithermanually by the user or automatically via the barrel assembly 370, thedistal tip 324 of the needle 320 no longer pierces the septum 314 asillustrated in FIG. 23. Accordingly, the septum 314 forms a fluid-tightseal and selectively prohibits fluid exchange to or from the catheter330. In other words, the septum 314 selectively permits or blocks theflow of fluid through the catheter 330 based on whether the septum 314is pierced by the septum actuator 360.

The needle 320 subsequently enters into the second needle position asillustrated in FIG. 25 where the distal tip 324 of the needle 320 isenclosed by the spring clip 340. As described above, the flexible arms344 of the spring clip 340 are biased by the needle 320 in the firstneedle position. When the needle 320 enters into the second needleposition, the lips 352 of the spring clip 340 are no longer biased onthe needle 320 and instead contact each other to enclose and shield thedistal tip 324 of the needle 320. As described above, the needle 320enters into the second needle position either manually by the user orautomatically using the barrel assembly 370.

In the second needle position, the flexible arms 344 also disengage fromthe openings 362 c of the septum actuator 360. Specifically, the highestportion of the spring clip 340 where the cutouts in the distal armportion 345 b and the top wall portion 351 a meet no longer protrudesfrom the openings 362 c of the septum actuator 360. This disengagementallows the needle 320 and the spring clip 340 to be removed from thecatheter adapter 332 as described below.

Next, the needle 320 moves to the third needle position. When thecatheter assembly 310 is cooperating with the barrel assembly 370 asillustrated in FIG. 24, the spring 382 surrounding the inner needle hubis released by the activation button 378 as described above. This causesthe inner needle hub to travel to the proximal, opposite end of thebarrel assembly 370 (not illustrated in FIG. 24 but illustrated inprevious embodiments). Thus, the needle 320 is now in a retracted, thirdneedle position, where the complete needle 320 (including its sharpdistal tip) and the spring clip 340 are retained in the outer housing ofthe barrel assembly 370. The inner needle hub holding the needle 320 isretained in the outer housing of the barrel assembly 370 via the forceexerted by the spring 382. Accordingly, the combination of the innerneedle hub, the outer housing and the spring 382 is an exemplary needleprotection member to enclose the needle 320.

Alternately, as illustrated in FIG. 26, the needle 320 can move to thethird needle position manually by the user. Specifically, since thespring clip 340 is now disengaged from the septum actuator 360, the usercan manually pull the needle 320 out of the catheter assembly 310. Theneedle deformation 322 in the needle 320 causes the spring clip 340 tobe removed with the needle 320 in a similar manner described above.

After initial use of the needle 320, further use of the catheterassembly 310 is described as follows. When the catheter 330 is initiallyinserted into a patient, the needle 320 is removed and the septum 314prevents blood from flowing out of the proximal end of the catheteradapter 332. As a male Luer connector is inserted in the catheteradapter 332, the end of the Luer connector abuts the septum actuator360. Further movement of the Luer connector moves the septum actuator360 into the first actuator position axially toward and engages theseptum 314. As the septum 314 is pierced (partially or fully), thedistal end of the septum actuator 360 separates one or more of the slitsto engage and open the septum 314. After the septum 314 is opened by theseptum actuator 360, fluid is permitted to flow from the Luer connector,through internal passages 362 a, the distal opening 362 b and theopenings 362 c of the septum actuator 360, and ultimately into thecatheter 330 or vice versa.

When the Luer connector is removed, the septum actuator 360 disengagesthe septum 314 via the elastic force from the septum 314 (or springforce as described above) and returns to the second actuator position.The septum actuator 360 is restrained from moving beyond the secondactuator position due to the engagement between the flange 366 of theseptum actuator 360 and the retention feature 334 in the catheteradapter 332.

Alternately, the septum actuator 360 remains engaged to the septum 314when the Luer connector is removed. Subsequently, the catheter assembly310 is discarded after use.

The foregoing detailed description of the certain exemplary embodimentshas been provided for the purpose of explaining the principles of theinvention and its practical application, thereby enabling others skilledin the art to understand the invention for various embodiments and withvarious modifications as are suited to the particular use contemplated.This description is not necessarily intended to be exhaustive or tolimit the invention to the precise embodiments disclosed. Any of theembodiments and/or elements disclosed herein may be combined with oneanother to form various additional embodiments not specificallydisclosed, as long as they do not contradict each other. Accordingly,additional embodiments are possible and are intended to be encompassedwithin this specification and the scope of the invention. Thespecification describes specific examples to accomplish a more generalgoal that may be accomplished in another way.

As used in this application, the terms “front,” “rear,” “upper,”“lower,” “upwardly,” “downwardly,” and other orientational descriptorsare intended to facilitate the description of the exemplary embodimentsof the present invention, and are not intended to limit the structure ofthe exemplary embodiments of the present invention to any particularposition or orientation. Terms of degree, such as “substantially” or“approximately” are understood by those of ordinary skill to refer toreasonable ranges outside of the given value, for example, generaltolerances associated with manufacturing, assembly, and use of thedescribed embodiments.

What is claimed is:
 1. A catheter assembly comprising: a cathetercarried by a catheter adapter; a needle having a sharp distal tip anddisposed in the catheter such that in a first needle position, theneedle extends beyond the catheter; a septum actuator having openingsextending through an outer wall of the septum actuator, the septumactuator disposed in the catheter adapter and configured to open aseptum; and a spring clip disposed in the septum actuator and engagingthe openings of the septum actuator in the first needle position;wherein the spring clip does not engage the catheter adapter.
 2. Thecatheter assembly of claim 1, wherein the spring clip includes one ormore flexible arms; the one or more flexible arms bias against theneedle in the first needle position; and the one or more flexible armsbias against each other to enclose the distal tip of the needle when theneedle is in a second needle position.
 3. The catheter assembly of claim2, wherein the one or more flexible arms engage the openings of theseptum actuator in the first needle position to prevent removal of thespring clip from the catheter assembly.
 4. The catheter assembly ofclaim 2, wherein the one or more flexible arms disengage the openings ofthe septum actuator in the second needle position to allow removal ofthe spring clip from the catheter assembly.
 5. The catheter assembly ofclaim 2, wherein the flexible arms each have a width smaller than awidth of the openings of the septum actuator.
 6. The catheter assemblyof claim 5, wherein the flexible arms each include a proximal armportion and a distal arm portion; the distal arm portion is narrower inwidth than the proximal arm portion; and the distal arm portion includesa curvature that is configured to eliminate contact with the opening ofthe septum actuator.
 7. The catheter assembly of claim 5, wherein theflexible arms each include a distal wall; the distal wall includes a topwall portion and a bottom wall portion; the top wall portion is narrowerin width than the bottom wall portion; and the top wall portion includesa curvature that is configured to eliminate contact with the opening ofthe septum actuator.
 8. The catheter assembly of claim 1, wherein whenthe needle is in a second needle position, the spring clip disengagesthe openings of the septum actuator.
 9. The catheter assembly of claim1, wherein the spring clip does not contact the catheter adapter. 10.The catheter assembly of claim 1, wherein the needle further includes adeformation; and the deformation is enclosed by the spring clip when theneedle is in a second needle position.
 11. The catheter assembly ofclaim 10, wherein the deformation in the needle is configured to causethe spring clip to axially move with respect to the septum actuator. 12.The catheter assembly of claim 1, wherein the catheter adapter includesa mating portion at a proximal end of the catheter adapter that isconfigured to engage a Luer device; and the mating portion has anengagement surface of at least 7.5 mm in length for engaging the Luerdevice.
 13. The catheter assembly of claim 1, wherein the septumactuator includes a distal opening in communication with an internalpassage that extends throughout a length of the septum actuator forfluid to flow when the septum is opened.
 14. The catheter assembly ofclaim 13, wherein the openings of the septum actuator extend through theseptum actuator in a direction substantially perpendicular to theinternal passage for flushing fluid.
 15. The catheter assembly of claim1, wherein the catheter adapter includes a retention feature; and theseptum actuator is retained in the catheter adapter by the retentionfeature.
 16. The catheter assembly of claim 1, wherein the needlemanually moves from the first needle position to a second needleposition.
 17. The catheter assembly of claim 1, wherein the septumactuator moves between a first actuator position to engage the septumand a second actuator position to disengage the septum; and a returnmember returns the septum actuator from the first actuator position tothe second actuator position.
 18. The catheter assembly of claim 1,further comprising: a spring disposed about the needle and extendingbetween a needle hub and a proximal end of a barrel assembly; and anactivation button movably mounted adjacent to a distal end of the barrelassembly and adapted for selective engagement with the needle hub tohold the needle hub adjacent to the distal end of the barrel assemblyagainst a bias of the spring in the first needle position; wherein whenthe activation button is depressed, the spring is released to move theneedle and the needle hub to a second needle position where the springclip encloses the distal tip of the needle and subsequently to a thirdneedle position where the needle and the spring clip are removed fromthe catheter adapter; and a needle protection member encloses the needlecompletely in the third needle position.
 19. The catheter assembly ofclaim 1, wherein the spring clip cooperates with a spring housing; aproximal end of the spring housing includes a tapered outer surface; theneedle moves to a second needle position enclosing the sharp distal tip;and when the needle moves to a third needle position, the spring housingis guided by an engagement between the tapered outer surface of thespring housing and a tapered inner surface of a barrel assembly todispose the spring clip and the spring housing into the barrel assembly.